Navigation Links
Cylex(TM) Receives ISO 13485:2003 and 9001:2000 Quality Certifications
Date:9/30/2008

ISO certification confirms implementation of quality systems in product

design and development, manufacture, and distribution for Cylex's

ImmuKnow(R) immune cell function assay

COLUMBIA, Md., Oct. 1 /PRNewswire/ -- Cylex has announced receipt of certification to ISO 13485:2003 and 9001:2000. The 13485:2003 certification includes compliance with the Canadian Medical Devices Conformity Assessment System (CMDCAS). These certifications signify compliance with internationally recognized standards in design, development, and manufacturing of medical products. The certifications were issued by TUV Rheinland of North America.

"This is a major achievement for the Company," stated Brad L. Stewart, president of Cylex. "ISO certification confirms that quality systems have been implemented in product design and development, manufacture, operations, shipping, and service and will support CE marking of Cylex products that will be labeled for in vitro diagnostic use for sale within the European Community. In addition, the certification confirms that Cylex meets global quality design and manufacturing requirements for Canada."

ISO 13485:2003 provides Cylex's customers with a "Quality Pledge" in regard to the Company's ongoing dedication to quality manufacturing, as well as demonstrating our readiness to take on the demanding challenges of building medical devices that are robust and reliable.

"In addition to the ISO 13485:2003 certificate, Cylex voluntarily elected to obtain certification to ISO 9001:2000 as well," Stewart went on to say. "We did this to demonstrate our commitment to customer focus, customer satisfaction, and continuous quality improvement. And I want to take this opportunity to clearly recognize all Cylex's employees for the dedication, focus, and hard work that has made this certification possible."

Certification to ISO standards is a baseline quality system requirement in many key markets for app
'/>"/>

SOURCE Cylex
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2

Related biology technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
5. IsoTis Receives FDA Clearance for Accell Family of Products
6. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
7. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
8. IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
9. XTL Receives Staff Letter From NASDAQ
10. XTL Receives Staff Letter From NASDAQ; XTL may Transfer its ADR Listing to the NASDAQ Capital Market
11. Hemo-Stream(TM) Chronic Dialysis Catheter Receives FDA Clearance

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/5/2009)... , Fuel economy ratings for the new 2010 model y...nomy.gov web site, which Oak Ridge National Labor...ent of Energy and the U.S. Environmental Protectio...fuel economy list are hybrid electrics, led by the...t proves that hybrids have gone mainstream," said ...
(Date:11/5/2009)...wswire-FirstCall/ -- ThermoGenesis Corp. (Nasdaq: ... for processing and storing adult stem cells, toda... 2010. ,, For the quarter ended September 30, 2..., a 15 percent increase over revenues of $4.5 mill...aid the key contributors to the growth in revenues...
(Date:11/5/2009)...e-FirstCall/ -- Wound Management Technologies, Inc...o a Letter of Intent to purchase all healthcare-re...(OTC Bulletin Board: VHGI). The deal provides for ...,000 shares of WNDM and a royalty agreement for re...gy being acquired from VHGI. WNDM closed at $2.0...
(Date:11/5/2009)...ialty firm BioSoteria announced that its Vice Pres...ified Professional in Learning and Performance&tra...r Training and Development (ASTD) Certification In...ears of medical communications and health care tra...pment of the company,s online pharmacovigilance cu...
Breaking Biology Technology:November 2009 story tips from the US Department of Energy's Oak Ridge National Laboratory 2November 2009 story tips from the US Department of Energy's Oak Ridge National Laboratory 3ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 2ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 3ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 4ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 5ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 6ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 7ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 8OTCBB-WNDM Announces LOI to Acquire VHGI Assets for $10 Million Cash/Stock 2OTCBB-WNDM Announces LOI to Acquire VHGI Assets for $10 Million Cash/Stock 3BioSoteria eLearning Executive Michelle Nolin Flewell Earns Certification 2BioSoteria eLearning Executive Michelle Nolin Flewell Earns Certification 3BioSoteria eLearning Executive Michelle Nolin Flewell Earns Certification 4
...s Include 80% SVR Rate with Nitazoxanide-Based Com...f Action of Nitazoxanide, SAN FRANCISCO, Nov. 3 ...tical company, today announced that data from stud...HCV) infection are being,communicated in three pre...American Association for the Study of Liver Diseas...
...LE, Calif., Nov. 3 Cepheid (Nasdaq:,CPHD) today a...eement to,acquire Stretton Scientific Limited, a p..., measuring and monitoring equipment based in,Stre...ibutes Cepheid,s,SmartCycler(R) System, among othe... group of medical customers including the National...
...ND, Ohio and LOD, Israel, November 3 Simbionix,US...simulators and hands-on,curriculum for training me...E. Lewandowski will join the company as the US Mar...r, Simbionix CEO stated, "Over the past two,consec...venue growth in,both our International and Domesti...
Other Biology Technology:Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at AASLD 2008 2Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at AASLD 2008 3Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at AASLD 2008 4Cepheid Accelerates Direct Sales Channel in UK With Pending Acquisition of Medical Distributor Stretton Scientific 2Cepheid Accelerates Direct Sales Channel in UK With Pending Acquisition of Medical Distributor Stretton Scientific 3William E. Lewandowski to Lead Simbionix US Marketing Team in Simbionix's Strategic Expansion in the US Market 2
(Date:11/4/2009)...CHAPEL HILL Scientists at the University of North...e University of California, San Francisco have dev...edict new target diseases for existing drugs. , ...hat compares how similar the structures of all kno...rtners -- known as ligands -- of disease targets w...
(Date:11/4/2009)...TTLE, Nov. 4 Glencoe Software, Inc...onment (OME) Consortium ( http://openmicroscopy.o... the American Society of Cell Biology,s exciting n...e ASCB has been awarded a $2.5M stimulus grant thr...nd Opportunities program, as part of the American ...
(Date:11/3/2009)...CA RATON, FL (November 4, 2009) For more than 25 ...ueen conch ( Strombus gigas ) have been unsuccessf...tary seeding techniques to produce beaded (nucleat...conch have been developed by scientists from Flori...ic Institute (HBOI). With less than two years of r...
Breaking Biology News(10 mins):Study points to new uses, unexpected side effects of already existing drugs 2Glencoe Software to Support the ASCB 'Stimulus Grant' to Build Virtual Image Library of the Cell 2Scientists are first to 'unlock' the mystery of creating cultured pearls from the queen conch 2Scientists are first to 'unlock' the mystery of creating cultured pearls from the queen conch 3Faced With Federal Prosecution MountainView Agrees to Stop Harassment of RNs in Settlement With Labor Board 5233 1Faced With Federal Prosecution MountainView Agrees to Stop Harassment of RNs in Settlement With Labor Board 5233 2Cocaine Addiction Vaccine Shows Some Success 58894 1Cocaine Addiction Vaccine Shows Some Success 58894 2Cocaine Addiction Vaccine Shows Some Success 58894 3VBI awarded 2427 million from NIH to support infectious disease research 10266 1VBI awarded 2427 million from NIH to support infectious disease research 10266 2VBI awarded 2427 million from NIH to support infectious disease research 10266 3VBI awarded 2427 million from NIH to support infectious disease research 10266 4
...By discovering the physical mechanism behind the r...tists at the University of Illinois have moved a s...ofluidic devices for drug delivery, water purifica...t transport of water in carbon nanotubes has gener...tube walls and their hydrophobic, or water-hating ...
...n immune system signaling and the production of sp... some primates are able to live with an immunodefi...-like illness, unlike other primate species, inclu...isease. , Following the identification of HIV (H...25 years ago, an extensive search was undertaken t...
...hairman of Singapore A*STAR,s Biomedical Research ... outstanding contribution to cancer research throu..., The Royal Gold Medal is one of the highest acco...iven to recipients whose intellectual endeavour ha...Dr. Lane termed the tumour suppressor, p53, which ...
Other Biology News:Simulations help explain fast water transport in nanotubes 2Why some primates, but not humans, can live with immunodeficiency viruses and not progress to AIDS 2Why some primates, but not humans, can live with immunodeficiency viruses and not progress to AIDS 3Why some primates, but not humans, can live with immunodeficiency viruses and not progress to AIDS 4
Rat IgG2b Clone: A95-1, Allophycocyanin Conjugated/Tagged from BD Biosciences Pharmingen
Rabbit Anti-Human Sphingosine 1-phosphate receptor Edg-1 Polyclonal Antibody, Unconjugated from GenWay Biotech, Inc.
Rat Albumin EIA Kit from Cayman Chemical
CMV IgM ELISA Kit, Single from Bio-Quant Inc.
Biology Products: